StelKast, a manufacturer and distributor of orthopedic implants for knee replacement and hip replacement, has received 510(k) clearance from the US Food and Drug Administration (FDA) to market EXp for the Proven Gen-Flex total knee system.
Exp, a blend of the antioxidant vitamin E (a-tocopherol) and a highly cross-linked polyethylene technology, was developed as an alternate bearing material in hip replacements.
The technology provides long-term oxidative stability that ensures lasting implant performance by preserving the mechanical properties.
StelKast senior vice president and general manager John Reyher said incorporating the company’s unique EXp polyethylene technology with its Proven Gen-Flex Total Knee System allows its knee patients to benefit from the extraordinary success currently offered by its hip products.
"EXp will further enhance the durability of our knee devices providing orthopedic surgeons with more advanced, cost-effective solutions for their patients," Reyher added.
Exp, which was introduced by StelKast in 2011, will now be available on the Proven Gen-Flex for both cruciate retaining and posterior stabilized knee systems.
EXp knee products are expected to be commercial launched in September 2013.
Proven Gen-Flex Total Knee System, a long-term quality solution, provides flexibility to the orthopedic surgeons for addressing patient needs.